Potential Rapid Battery Depletion Due To Circuit Component

Viva™ CRT-D and Evera™ ICDOriginal Date of Communication:
August 2016

Product

A specific subset of 78 VivaCRT-D and Evera ICD may experience rapid battery depletion due to a low resistance path developing within a circuit component.You may use the "Search for Information by Serial Number" tool on home page of this web site to determine if a specific device is affected.

Advisory

Devices in the affected population may experience rapid battery depletion due to a low resistance path developing within a circuit component. This is not related to a failure within the battery.

Development of a low resistance path in the circuit component in some cases has been reported to cause battery depletion in seven (7) days or less and may present clinically during a patient follow-up visit as:

One or more electrical resets, which will display as an observation on the programmer.

No pacing or defibrillation therapy output.

No telemetry.

Programmer screen display of “SERIOUS DEVICE MEMORY FAILURE.”

Patient audible alerts and CareAlerts™ may not reliably notify the patient or clinician, due to this issue.

Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.

Patient Management Recommendations

We realize that each patient requires unique clinical consideration and we support your judgment in caring for your patients. After consultation with Medtronic’s Independent Physician Quality Panel, Medtronic offers the following options for managing patients implanted with an affected device:

Advise patients to seek medical attention immediately if they experience symptoms (e.g., fainting or lightheadedness) or if the audible patient alert sounds.

For pacemaker-dependent patients or those at a higher risk of Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF):

Physicians should consider device replacement.

For patients where the physician does not believe device explant is the best course of action, Medtronic offers these additional options:

Program the audible alerts for “Low Battery Voltage RRT” to “On-High”. It is possible that alerts may not sound if the battery is depleted. Therefore physicians should also consider one of the following:

Device operation may be monitored frequently (e.g., daily) by patients placing the magnet over the device for 1-2 seconds and then removing the magnet. If the device is functional, a steady tone will sound for approximately 10 seconds. If no tone or an oscillating high/low tone is heard, advise patients to seek care immediately.

Prescribe either a CareLink™ transmission be performed by the patient, or a maintenance transmission by the clinic, on a more frequent basis (e.g., weekly or daily) based on the unique patient considerations. The clinic should review these transmissions upon receipt.

If the transmission is unsuccessful the patient should be brought into the clinic for immediate follow-up as this may be an indication that the device battery has depleted to a level where it can no longer support telemetry.

Review transmissions for any signs of this issue (e.g., one or more electrical resets, or notification that a device alert has occurred).

Each transmission will decrease battery longevity by approximately one day.

STATUS UPDATE - MAY 2020

Within the 78 devices, there have been 10 confirmed failures (13%) through April 22,2020. Medtronic modeling predicts an additional three (3) failures may occur in the remaining active population. An estimated 28 devices remain active

Initial Affected Population

Number of Confirmed Advisory Related Events

Estimated Remaining Active Population

Current Malfunction Rate (confirmed malfunctions over total population)